目的：采用Meta分析法评价抗结核固定剂量复合剂（fixed-dose combination,FDC）治疗初治肺结核的疗效及安全性。方法：使用计算机检索PubMed、Web of Science、中国知网、万方数据知识服务平台、维普网等数据库公开发表的抗结核固定剂量复合制剂治疗初治肺结核的相关文献,时间限定为建库起至2024年10月。关键词包括“肺结核”“化疗”“固定剂量复合剂”“tuberculosis”“Fixed-dose Combination”。实验对象均为初治肺结核患者,实验组采用抗结核FDC治疗,对照组采用传统板式药治疗。提取纳入文献的资料,包括第一作者、发表年份、样本量等;采用Cochrane评价法评价纳入文献的质量;主要结局指标包括2月末及治疗末痰转阴情况、治疗有效率、不良反应发生率、阴影吸收情况、空洞闭合情况。Meta分析采用Stata MP 18和RevMan 5.4软件;最后采用Begg's和Egger's检验对发表偏移进行分析。结果：最终纳入9篇文献,共包含实验组4 680例及对照组4 712例,各文献的选择偏倚均为低风险。Meta分析结果显示,实验组2月末痰转阴情况（RR=1.05,95%CI：1.03~1.07）、治疗末痰转阴情况（RR=1.04,95%CI：1.03~1.05）、治疗有效率（RR=1.04,95%CI：1.02~1.05）、阴影吸收率（RR=1.07,95%CI：1.04~1.09）、空洞闭合率（RR=1.04,95%CI：1.02~1.05）高于对照组;不良反应发生率（RR=1.01,95%CI：0.93~1.09）差异无统计学意义;漏斗图结果显示以上效应指标发表偏倚均较小。结论：抗结核FDC与单纯四联抗结核方案相比,2月末及治疗末痰转阴率、治疗有效率、阴影吸收率、空洞闭合率均提高;不良反应发生率相差不大。

Objective Meta-analysis was used to evaluate the efficacy and safety of anti-tuberculosis fixed-dose combination (FDC) in the treatment of primary tuberculosis. Methods A computerized search was conducted to identify publicly available literature on the treatment of primary tuberculosis with anti-tuberculosis fixed-dose combinations in PubMed, Web of Science, China Knowledge, Wanfang Data Knowledge Service Platform, and Wipu. com databases for the period from the time of database creation to October 2024. The keywords included “tuberculosis”, “chemotherapy”, “fixed-dose combination”, “tuberculosis”, “Fixed-dose Combination”. The experimental subjects were patients with primary tuberculosis, and the experimental group was treated with anti-tuberculosis FDC, while the control group was treated with traditional plate drugs. The information of the included literature was extracted, including the first author, year of publication, sample size, etc.; Cochrane evaluation method was used to evaluate the quality of the included literature; the main outcome indicators included sputum conversion at the end of February and at the end of the treatment, treatment efficiency, incidence of adverse effects, shadow absorption, and cavity closure. Meta-analysis was performed using Stata MP 18 and RevMan 5.4 software; Finally, publication bias was analyzed using Begg′s and Egger′s tests. Results Nine papers were finally included, containing a total of 4 680 cases in the experimental group and 4 712 cases in the control group, and the selection bias of each paper was low risk. Meta-analysis showed that the sputum conversion at the end of February in the experimental group (RR=1.05, 95% CI: 1.03-1.07), sputum conversion at the end of treatment (RR=1.04, 95% CI: 1.03-1.05), treatmentefficiency (RR=1.04, 95% CI: 1.02-1.05), shadow absorption rate (RR=1.07, 95% CI: 1.04-1.09), and cavity closure rate (RR=1.04, 95% CI: 1.02-1.05) were higher than those of the control group; the incidence rate of adverse reactions (RR=1.01, 95% CI: 0.93-1.09) was not statistically significant; the funnel plot results showed that the publication bias of the above effect indicators were small. Conclusion Anti-tuberculosis FDC increased the sputum conversion rate, treatment efficiency, shadow absorption rate, and cavity closure rate at the end of 2 months and at the end of treatment when compared with the quadruple anti-tuberculosis regimen alone for the treatment of first-treatment tuberculosis; there was little difference in the incidence of adverse reactions.